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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Medical Device Notification: HIV-1/HIV-2 Plus O EIA Testing Software-DiaSporin, Inc

DATE NOTIFICATION INITIATED:

 

May 13, 2004

 

PRODUCT:

 

HIV-1 / HIV-2 Plus O EIA Testing Software

MANUFACTURER:

 

DiaSorin, Inc
Stillwater, Minnesota

 

REASON:

 

An error was contained on the ETI-LAB Applications disk for programming the BioRad HIV-1/HIV-2 Plus O assay. The error induced specimen and conjugate incubation temperatures for the assay to remain at ambient temperature rather than the required 37°C temperature. Consignees will receive replacement disks.

 

 

Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448